BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALLURA XPER FD

    MDR report key: 15655769 · Received October 21, 2022

    Report

    Report Number
    3003768277-2022-00614
    Event Type
    Malfunction
    Date Received
    October 21, 2022
    Date of Event
    September 22, 2022
    Manufacturer
    PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
    Product Code
    OWB
    UDI-DI
    00884838054202
    PMA / PMN Number
    K161563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS HAS INVESTIGATED THIS COMPLAINT. ACCORDING TO THE ADDITIONAL INFORMATION COLLECTED, THE DEVICE WAS NOT IN CLINICAL USE WHEN THE ISSUE OCCURRED. A PHILIPS REMOTE SERVICE ENGINEER (RSE) EVALUATED THE SYSTEM AND FOUND THAT WORKLIST ACQUISITION ERROR WAS DISPLAYED BECAUSE OF THE ISSUE IN RADIOLOGY SERVER. BEFORE STARTING THE EXAMINATION, THE WORKLIST WAS ACQUIRED BY THE DEVICE, BUT AT THAT TIME, IT WAS NOT POSSIBLE TO ACQUIRE IT DUE TO A SETTING ERROR SUCH AS THE CHARACTER SET. IT WAS POSSIBLE TO MANUALLY REGISTER THE PATIENT'S NAME ON THE EQUIPMENT BEFORE THE EXAMINATION, AND THERE WAS NO PROBLEM WITH THE EXAMINATION. PROBLEMS SUCH AS CHARACTERS OF PATIENT DATA TARGETED FOR DATA ON THE MWM SERVER SIDE. THE ISSUE HAS BEEN RESOLVED BY RECONFIGURING THE SERVER AND RETURNED THE DEVICE IN GOOD WORKING ORDER. AT THE TIME THIS COMPLAINT WAS RECEIVED, PHILIPS DID NOT HAVE ENOUGH INFORMATION TO EXCLUDE THE POTENTIAL FOR DEATH OR SERIOUS INJURY ON RECURRENCE, AND AS SUCH THE COMPLAINT WAS REPORTED. SINCE THAT TIME, NEW INFORMATION HAS BEEN RECEIVED WHICH HAS LED TO THE DETERMINATION THAT THIS IS SCENARIO IS NOT LIKELY TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF IT WERE TO RECUR. THERE WAS NO MALFUNCTION WITH PHILIPS SYSTEM AND ISSUE IS WITH MWM SERVER. BASED ON THE INVESTIGATION RESULTS, PHILIPS CONCLUDED THAT THE COMPLAINT IS NOT REPORTABLE. THE CODES WERE UPDATED BASED ON THE INVESTIGATION OUTCOME. DEVICE PROBLEM AND HEALTH IMPACT CODES WERE CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A PROCEDURE, THE ALLURA XPER FD20 COULD NOT ACQUIRE THE MWM. NO PATIENT INJURY OR HARM WERE REPORTED IN ASSOCIATION WITH THIS EVENT. AN INVESTIGATION HAS BEEN OPENED TO IN TO EVALUATE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1928350 ALLURA XPER FD INTERVENTIONAL FLUOROSCOPIC X-RAY SYSTEM OWB PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. ALLURA XPER FD20 00884838054202

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown